# AstraZeneca PLC Lynparza approved in the EU for 1st-line maintenance treatment

- Link: https://www.directorstalkinterviews.com/astrazeneca-plc-lynparza-approved-in-the-eu-for-1st-line-maintenance-treatment/412785317
- Published: 2019-06-18T07:24:54+01:00
- Author: Giles Arbor

**[AstraZeneca plc](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l)**(
[LON: AZN](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l))
and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US
and Canada) have today announced that the European Commission (EC) has approved 
Lynparza (olaparib) as a 1st-line maintenance treatment for women with BRCA-mutated
advanced ovarian cancer.

The licensed indication is as a maintenance treatment of adult patients with advanced(
FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial
ovarian, fallopian tube or primary peritoneal cancer who are in response (complete
or partial) following completion of 1st-line platinum-based chemotherapy.

**Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: **

> “This approval sets the stage for a new standard of care in the EU for women with
> ovarian cancer and a BRCA mutation. The goals of front-line therapy have always
> been long-term remission and even cure, yet currently 70% of patients relapse 
> within three years of initial treatment. The progression-free survival benefit
> of Lynparza observed in SOLO-1 represents a major step forward in our ambition
> to help transform patient outcomes.”

**Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief
Medical Officer, MSD Research Laboratories, said: **

> “In SOLO-1, Lynparza demonstrated clinically-meaningful results with a 70% reduction
> in the risk of disease progression or death in the first-line maintenance treatment
> of patients with BRCAm advanced ovarian cancer. Merck and AstraZeneca are committed
> to improving outcomes for people with cancer and we will work to bring this new
> option to women in the EU, many of whom have historically poor outcomes, as quickly
> as possible.”

The EC approval was based on data from the pivotal Phase III SOLO-1 trial which 
tested Lynparza as maintenance monotherapy compared with placebo in patients with
BRCAm advanced ovarian cancer following 1st-line platinum-based chemotherapy. Results
announced in October 2018 at 40.7 months of follow-up showed the median time of 
progression for patients treated with Lynparza had not yet been reached vs. 13.8
months for those on placebo (HR 0.30 [95% CI, 0.23-0.41], p<0.001).

This is the third indication for Lynparza in the EU. AstraZeneca and MSD are exploring
additional trials in ovarian cancer, including the ongoing Phase III PAOLA-1 trial,
which is testing Lynparza in combination with bevacizumab as a 1st-line maintenance
treatment for women with newly-diagnosed, advanced, stage IIIB-IV high grade serous
or endometrioid ovarian cancer, regardless of BRCA status.

**About SOLO-1**

SOLO-1 was a Phase III, randomised, double-blinded, placebo-controlled, multi-centre
trial to evaluate the efficacy and safety of Lynparza tablets (300mg twice daily)
as a maintenance monotherapy compared with placebo in patients with BRCAm advanced
ovarian cancer following first-line platinum-based chemotherapy. The trial randomised
391 patients with a deleterious or suspected deleterious germline or somatic BRCA1
or BRCA2 mutation who were in clinical complete or partial response following platinum-
based chemotherapy.

Patients were randomised (2:1) to receive Lynparza or placebo for up to two years
or until disease progression. Patients who had a partial response at two years were
permitted to stay on therapy at the investigator’s discretion. The primary endpoint
was progression-free survival (PFS) and key secondary endpoints included time to
second disease progression or death, time to first subsequent treatment and overall
survival.

The data were presented on 21 October 2018, at the Presidential Symposium of the
ESMO (European Society for Medical Oncology) 2018 Congress in Munich, Germany and
published simultaneously online in The New England Journal of Medicine.

**Summary of PFS**^(i,ii)

|   | Lynparza (n=260) | Placebo (n=131) | 
| Number of patients with event (%)^(iii) | 102 (39) | 96 (73) | 
| Median PFS (in months) | Not reached | 13.8 | 
| Hazard ratio (95% CI) | 0.30 (0.23-0.41) | 0.30 (0.23-0.41) | 
| P-value | p<0.001 | p<0.001 |

i Investigator-assessed.

ii Median (interquartile range) duration of follow-up 40.7 months (34.9-42.9) for
Lynparza and 41.2 months (32.2-41.6) for placebo.

iii Analysis was done at 50.6% maturity.

The SOLO-1 safety profile was in line with that observed in prior clinical trials.
The most common adverse events (AEs) ≥ 20% were nausea (77%), fatigue (63%), vomiting(
40%), anaemia (39%) and diarrhoea (34%). The most common ≥ Grade 3 AEs were anaemia(
22%) and neutropenia (9%). Some 71% of patients on Lynparza remained on the recommended
starting dose. Additionally, 88% of patients on Lynparza continued treatment without
an AE-related discontinuation.

Financial considerations

Under the oncology collaboration with MSD and following this new approval for Lynparza,
AstraZeneca will receive $30m as Ongoing Collaboration Revenue, anticipated to be
booked by the Company during the second quarter of 2019.

Share on: